Plant Protection Products Regulation 2011

Original Language Title: Pflanzenschutzmittelverordnung 2011

Subscribe to a Global-Regulation Premium Membership Today!

Key Benefits:

Subscribe Now for only USD$20 per month, or Get a Day Pass for only USD$4.99.

233. Regulation of the Federal Minister for Agriculture, Forestry, Environment and Water Management for the implementation of the Plant Protection Products Act 2011 (Plant Protection Products Regulation 2011)

Due to § 6 of the Plant Protection Products Act 2011, BGBl. I No 10/2011, shall be arranged:

table of contents

§ 1

Levy, acquisition and storage

§ 2

Education and training

§ 3

Certificate

§ 4

Operating Registry

§ 5

Register of plant protection products

§ 6

Reporting requirements

§ 7

Marking

§ 8

Pre-packages

§ 9

Experimental equipment

§ 10

Information requirements

§ 11

Approval for the house and small garden area

§ 12

Approval of Nützlingen

§ 13

Sales Extension

§ 14

Supervision

§ 15

Entry into force and transitional provisions

§ 16

References to legislation

Levy, acquisition and storage

§ 1. (1) In the case of the sale of plant protection products, sufficient staff must be available, which is in possession of a certificate (§ 3), in order to provide the customers with appropriate information on the use of plant protection products, information on the risks for the human health and the environment, as well as safety information for risk management on the products in question.

(2) Plant protection products authorised for professional use may only be sold to persons who are in possession of a certificate under Article 5 of Directive 2009 /128/EC.

(3) Paragraph 1 shall not apply to drogists in the exercise of the trade in accordance with § 104 of the Industrial Regulations 1994 and very small distributors in the retail trade which only sell plant protection products for the home and small garden sector. Very small distributors are distributors in the retail trade, which do not sell more than 100 kg of plant protection products in the calendar year. This quantity regulation applies to companies with several locations for each branch holding. However, in all companies with more than five branch establishments, at least one person in charge of the company must have a certificate in accordance with § 3, each 20 stores must have at least one person in possession of a certificate in accordance with § 3; In addition, these companies are obliged to set up an internal training system.

(4) distributors selling plant protection products for the home and small garden sector shall have information to the customer within the meaning of Article 6 (3) of Directive 2009 /128/EC on the risks of the use of plant protection products for human beings health and the environment, in particular on the risks, exposure, proper storage, handling, use and safe disposal, as well as low-risk alternatives. The marketing authorisation and authorisation holders of plant protection products shall provide the distributors with the relevant information.

(5) An activity as a consultant in the context of the distribution of plant protection products for professional use may only be carried out by persons who are in possession of a certificate (§ 3).

(6) Drivers within the meaning of paragraph 3, in which it is not possible for technical reasons (for example, lack of space on invoices or cash receipts) to complete all information within the meaning of Section 11 (2) of the Plant Protection Act 2011 , by means of appropriate intra-company records, to ensure, in a comprehensible manner, that the names used (for example, the product number or the name of the product) have a clear allocation of the product to the authorised plant protection products.

(7) Plant protection products shall be stored by distributors in such a way that no unintended release or mixing with other products, in particular food and feed, may occur.

Education and training

§ 2. (1) The implementation of the initial and further training provided for in Annex I to Directive 2009 /128/EC for distributors and consultants in distribution for the purpose of obtaining the certificate is the responsibility of the Federal Office for Food Security and the Austrian Economic Chamber. These are empowered to transfer this task to qualified persons who offer training courses within the meaning of paragraph 2 and which are demonstrably carried out in the intended scope.

(2) The total duration of the training shall be sixteen hours and that of the training shall be eight hours, providing for a balanced conciliation of the subjects listed in Annex I to Directive 2009 /128/EC, the content and scope of which shall be provided by the Federal Office for Food security shall be established. A confirmation is to be issued on the course attendance.

(3) The education and training of nationals of a Member State of the European Union or of a Contracting State of the European Economic Area in accordance with Article 5 of Directive 2009 /128/EC in a Member State of the European Union or of a Member State of the European Economic Area The contracting state of the European Economic Area shall be deemed to be education and training within the meaning of the Regulation, if it can be presented in the original and, if necessary, it can be furnished in certified translation. A certificate pursuant to § 3 may be issued upon request.

Certificate

§ 3. (1) The certificate must be issued by the Federal Office of Food Security after presentation of the confirmation of a course visit (§ 2 para. 2); it shall contain, in particular, the following information:

1.

"certificate referred to in Article 5 of Directive 2009 /128/EC",

2.

the certification body,

3.

Name, address, date of birth, photograph and signature of the owner,

4.

serial number,

5.

Date of issue and

6.

Expiration date.

(2) The certificate shall be valid for a period of six years. If the initial and further training is completed before 26 November 2015 or before the end of the six-year period, the validity of the certificate-except in the case of paragraph 3-is extended by this period of time.

(3) If a administrative penalty is imposed in accordance with § 15 of the Plant Protection Act 2011, a further training course must be completed within one year in the minimum amount of eight hours, otherwise the certificate shall be issued by the Federal Office for To withdraw food security. The Federal Office for Food Safety shall transmit the certificates withdrawn. If a further administrative penalty is imposed in accordance with § 15 of the Plant Protection Act 2011 against the certifying holder within three years, the certificate can be withdrawn immediately.

Operating Registry

§ 4. (1) The registration shall be effected by registering the holding in an official directory pursuant to § 4 (1) of the Plant Protection Products Act 2011, which is to be published by the Federal Office for Food Security. With the registration for the purpose of registration, the company name, including legal form, company address as well as branches and branch offices are to be disclosed. A form to be published in the Official Messages of the Federal Office for Food Security shall be used for the notification.

(2) The registration is to be withdrawn or not to be effected if the registrant has given up registered office or establishment in Germany.

Register of plant protection products

§ 5. (1) Plant protection products authorised and approved as well as distribution extensions (§ 13) must be entered in the Register of Plant Protection Products with a serial number (authorisation number) until the end of the period of application. The Register of Plant Protection Products pursuant to Section 4 (2) of the Plant Protection Products Act 2011 is to be published by the Federal Office for Food Security.

(2) The register of plant protection products shall be entered in the following:

1.

the date and duration of the authorisation, the approval or the distribution of the distribution,

2.

renewal, cancellation and modification of the authorisation, approval or distribution of the sales,

3.

Periods of application in accordance with Article 46 of Regulation (EC) No 1107/2009,

4.

the information referred to in Article 65 of Regulation (EC) No 1107/2009,

5.

Reference Member State of the plant protection product authorised in accordance with Article 40 of Regulation (EC) No 1107/2009, and the trade name and registration number under which it is placed on the market in the reference Member State, and

6.

The Member State of origin of the plant protection product, approved in accordance with Article 52 of Regulation (EC) No 1107/2009, and the trade name and approval or registration number under which it is placed on the market in the Member State of origin.

(3) The authorisation, authorisation or notification (Section 15 (8)) of a plant protection product shall be issued if the annual plant protection registration fee has not been paid in accordance with Section 6 (6) of the GESG, despite the reminder.

Reporting requirements

§ 6. (1) The marketing authorisation holders and the placing on the market in accordance with § 15 (8) shall report to the Federal Office for Food Security in writing within two months of the end of the calendar year:

1.

the names (in accordance with internationally recognised or equivalent transport names) and the quantities of each active substance which they place on the domestic market each year and which they have spent annually by them from the domestic territory plant protection products and

2.

the trade names, authorisation numbers and quantities of the individual plant protection products which are marketed annually by them in the country and which have been brought annually by them from the country of the country.

(2) The marketing authorisation holders and the placing on the market in accordance with § 15 (8) have to report to the Federal Office for Food Security without delay in writing:

1.

all observations and data subsequently made known to them which are not in conformity with the conditions of authorisation or approval, in particular any new information on the potentially dangerous effects of a plant protection products, or their residues, on human and animal health or on groundwater, or on potentially dangerous environmental influences,

2.

the change in the manufacturer of an active substance or preparation and the task of the seat or establishment in the European Union;

3.

Amendment, renewal or termination of authorisation in the reference Member State in the case of Article 40 and in the Member State of origin in the case of Article 52 of Regulation (EC) No 1107/2009, and

4.

Amendment, renewal or termination of the authorisation in the reference Member State of plant protection products authorised in accordance with Article 12 (1) and (2) of the Plant Protection Products Act 1997.

(3) The registration holders shall notify the Federal Office of Food Security of a change in the data pursuant to § 4 (1) without delay in writing.

Marking

§ 7. (1) The marking must be in accordance with the requirements of Article 65 of Regulation (EC) No 1107/2009, and must be in general understandable in German, clearly visible and legible and permanently affixed. Other information or arrangements other than those provided for in Regulation (EC) No 1107/2009 must be clearly set out in the labelling and must not be misleading.

(2) Plant protection products referred to in Article 52 of Regulation (EC) No 1107/2009 may be placed on the market with a new marking only if, by means of the corresponding internal records, the information referred to in Article 52 (4) (4) (2). (a) to (c) of Regulation (EC) No 1107/2009 and of the batch number of the original product, a classification of the product to the plant protection product authorised in the Member State of origin is ensured in a comprehensible manner. The batch number of the formulation of the original product and the date of manufacture must continue to be clearly visible and legible on the packaging.

(3) In addition, the number of pre-packed pre-packed packages shall be indicated on overpackings.

Pre-packages

§ 8. Plant protection products according to § 23 of the Chemicals Act 1996 have to comply with the requirements laid down therein. Otherwise, plant protection products may only be placed on the market in undamaged and safe pre-packed packages. They must be such that, in the event of proper storage and handling, the plant protection products contained in them may not cause any risk to human or animal health or to the environment until they are consumed. The pre-packs shall in particular meet the following requirements:

1.

they must be manufactured and made in such a way that the content cannot inadvertently reach out to the outside,

2.

the materials of the prepackages and of the closures must be so designed that they cannot be attacked by the content and cannot enter into any dangerous connections; if necessary, the prepackages shall also be provided with: to provide child-safe closures,

3.

the pre-packs and the closures must be so firm and so strong in all parts that they can withstand the expected stresses, and

4.

the containers with closures, which can be re-used after opening, must be such that the pre-filled package can be closed several times in such a way that the contents cannot inadvertently reach the outside of the container.

Experimental equipment

§ 9. (1) Test facilities for the testing of efficacy and phytotoxicity are the Austrian Agency for Health and Food Safety GmbH and the Federal Research and Training Centre for Forest, Natural Hazas and Landscape.

(2) The Federal Office for Food Security shall, upon request, recognise other establishments as experimental facilities if they are granted the conditions laid down in Article 29 (3) of Regulation (EC) No 1107/2009, where appropriate under grant of conditions and conditions.

(3) The Federal Office for Food Security shall repeal the recognition if the test facilities no longer fulfil the conditions laid down in paragraph 2 above.

(4) Official or officially recognised testing facilities of other Member States shall be equivalent to domestic experimental facilities.

Information requirements

§ 10. (1) The Federal Office for Food Security shall carry out the necessary measures within the meaning of Article 7 (1) of Directive 2009 /128/EC.

(2) The Federal Office for Food Safety has the right to provide information on the assumption that plant protection products pose an unacceptable risk to human or animal health. information.

Approval for the house and small garden area

§ 11. (1) Plant protection products which are used in the domestic and small garden areas are subject to special authorisation requirements.

(2) Plant protection products for the domestic and small garden areas must be so designed that they can be safely used by non-professional users without specific plant protection knowledge. The pack sizes must be applied to the application in the home and small garden areas and shall be limited to a maximum area of 500 m². The plant protection products must be rapidly dismantled from their properties, be safe for the user and the environment, and must not be at least as T + (very toxic), T (toxic) or C (corrosive), and "carcinogenic", "mutagenic" or "toxic to reproduction" shall be classified or labelled in accordance with Directive 1999 /45/EC. Plant protection products which are classified or labelled as Xn (harmful) or Xi (irritant) or which have a special hazard potential for the natural household and groundwater can be used for the house and small garden areas (case-by-case examination) where the nature of the formulation, dosing device, packaging and application ensures that, in the case of a proper and appropriate use or as a result of such an application, a risk to Humans, animals, natural households and groundwater are excluded.

(3) The Federal Office for Food Security shall, in addition to the requirements laid down in paragraph 2, impose further restrictions and conditions in the framework of the authorisation for the house and small garden areas, insofar as this is in individual cases on the basis of the properties of the plant protection product and of the active substances contained therein. These include, in particular, the type of packaging and the form of the application, as well as the pre-writing of special dosing systems or application aids.

(4) Plant protection products for the home and small garden areas shall be marked in the labelling specifically with "For use in the home and small garden areas".

Approval of Nützlingen

§ 12. (1) Macroorganisms, other than vertebrate animals, and their ingredients with a general or specific effect against harmful organisms on plants, parts of plants or plant products, are considered to be plant protection products ("Nützlinge").

(2) The placing on the market of beneficial products intended for use in accordance with the provisions of Article 2 (1) of Regulation (EC) No 1107/2009 shall be permitted only if the Federal Office for Food Safety has been approved for this purpose.

(3) The application for authorisation shall, in particular, include the information, documents and samples required for the examination of the conditions of admission, with a view to unacceptable adverse effects and risks on the environment (with special regard to the of any accidental introduction or spread of invasive species), as well as biodiversity. With regard to other admission requirements, the requirements may be made easier, depending on the properties of the useable product.

(4) The authorisation shall be limited to a maximum of 15 years.

Sales Extension

§ 13. (1) A plant protection product may also be placed on the market for the first time by persons other than the marketing authorisation holder on the basis of an agreement with the marketing authorisation holder under a different name. The marketing authorisation holder shall conclude the agreement, indicating the name and address of the person entitled to the contract and the other name under which the plant protection product is to be placed on the market by the authorised person, the Federal Office of the Federal Republic of Germany for food security.

(2) A plant protection product within the meaning of paragraph 1 may only be placed on the market with:

1.

the divergent designation,

2.

the name and address of the beneficiary; and

3.

the sales number issued by the Federal Office for Food Security on the basis of the sales expansion.

(3) The sales product shall be subject to the same requirements as the reference product and the authorized person shall be subject to the same obligations as the marketing authorisation holder. Amendments to an agreement as referred to in paragraph 1 shall not affect plant protection products already on the market. Article 46 of Regulation (EC) No 1107/2009 shall apply.

Supervision

§ 14. (1) Only persons who have an education within the meaning of § 2 may be entrusted by the Federal Office for Food Security (Bundesamt für nutritional security) with the control which is capable of carrying out a training within the meaning of § 2.

1.

take the necessary measures to prevent infringements of the rules on plant protection legislation and, where appropriate, to report or to issue an objection,

2.

give instructions and information in order to avoid infringements of plant-protection legislation,

3.

To inform economic operators and consumers about the broad guidelines of the plant protection legislation and its enforcement.

(2) The requirements laid down in paragraph 1 are fulfilled, who is responsible for the successful completion of a course (paragraph 1). 3).

(3) The course is carried out by the Federal Office for Food Security and comprises a theoretical and practical part in the amount of up to ten days.

(4) The supervisory bodies shall complete at least every five years a further training of a total of at least two days.

(5) Persons who do not comply with the requirements laid down in paragraph 2 may be used to carry out the sampling, to the extent that such persons have been adequately trained and the knowledge and skills acquired have been demonstrated by means of a certificate.

(6) Within the framework of the practical training and further training of supervisory bodies, organs of the Federal Office for Food Security shall carry out on-the-spot hacons.

(7) If deficiencies are identified by the Board of Supervisors in the event of an on-the-spot check, which requires the setting of a measure pursuant to Article 10 (5) of the Plant Protection Products Act 2011, the Board of Supervisors shall have the person responsible for the illegality of the act in order to clarify the identified deficiencies and the measures ordered in the minutes.

Entry into force and transitional provisions

§ 15. (1) This Regulation, with the exception of Article 1 (1) to (5), shall enter into force on 14 June 2011.

(2) § 1 (4) shall enter into force on 26 November 2011 and § 1 para. 1, 2, 3 and 5 on 26 November 2015.

(3) procedures relating to plant protection products already authorised before 14 June 2011, or pending before 14 June 2011, shall continue, except at the request of the applicant, in accordance with the legal situation in force until that date; in so far as the legislation of the European Union does not conflict.

(4) On applications for admission pursuant to § 9 or § 12 (1) and (2) of the Plant Protection Products Act 1997, which will be submitted by 13 June 2011, the decision shall be taken on the basis of the legal situation in force before 14 June 2011.

(5) Authorisations of plant protection products in accordance with Section 12 (1) and (2) of the Plant Protection Products Act 1997 shall remain, except for a premature termination of the authorisation in the reference Member State, pending the final renewal of the authorisation in accordance with Art. 43 of Regulation (EC) No 1107/2009.

(6) Article 40 of Regulation (EC) No 1107/2009 is to be applied to authorised plant protection products in a reference Member State which have been assessed in accordance with the "uniform principles" in accordance with Annex VI to Directive 91 /414/EEC.

(7) Plant protection products which do not have a classification within the meaning of Article 31 (4) (d) of Regulation (EC) No 1107/2009 shall apply as from 26 November 2015 as being suitable exclusively for professional users and shall no longer be applicable to the Use in the house and small garden areas are given.

(8) Plant protection products according to § 3 (4) of the Plant Protection Products Act 1997 may be subject to the condition that the authorisation is still maintained in the Member State of origin and the conformity with the legislation of the European Union is given , is to be placed on the market by 31 December 2013 with a label corresponding to the provisions of the Plant Protection Products Act 1997.

(9) Bewilligungen for scientific experiments according to § 26 of the Plant Protection Products Act 1997 and confirmations for the import in accordance with § 27 of the Plant Protection Products Act 1997 remain upright.

(10) Applications for the provisional authorisation of plant protection products in accordance with § 9 of the Plant Protection Products Act 1997, which contain a new active substance to which the transitional provision of Article 80 (1) (lit) is included. (a) Regulation (EC) No 1107/2009 is also applicable after 14 June 2011.

References to legislation

§ 16. This Regulation provides for the following European Union Directive and Regulations, together with the implementing regulations based on them, in so far as they concern the scope of the Plant Protection Products Act 2011, in each of the applicable laws. Version implemented and completed:

1.

Regulation (EC) No 1107/2009 concerning the placing of plant protection products on the market and repealing Directives 79 /117/EEC and 91 /414/EEC, OJ L 327, 31.12.2009, p. No. OJ L 309, 24.11.2009 S 1;

2.

Directive 2009 /128/EC establishing a framework for Community action to ensure the sustainable use of pesticides, OJ L 327, 28.12.2009, p. No. OJ L 309, 24.11.2009 p. 71, with the exception of biocidal products in accordance with the Biocidal Products Act, BGBl. I No 105/2000;

3.

Regulation (EC) 178/2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority, and laying down procedures in matters of food safety, OJ L 327, 31.12.2002, p. No. OJ L 31, 1.2.2002, p. 1;

4.

Implementing Regulation (EU) No 540/2011 on the implementation of Regulation (EC) No 1107/2009 as regards the list of authorised active substances, OJ L 327, 31.12.2009, p. No. OJ L 153, 11.6.2011 p. 1;

5.

Regulation (EU) No 544/2011 implementing Regulation (EC) No 1107/2009 as regards the data requirements for active substances, OJ L 327, 30.11.2011, p. No. OJ L 155, 11.6.2011 p. 1;

6.

Regulation (EU) No 545/2011 on the implementation of Regulation (EC) No 1107/2009 as regards the data requirements for plant protection products, OJ L 378, 27.10.2009, p. No. OJ L 155, 11.6.2011 p. 67;

7.

Regulation (EU) No 546/2011 on the implementation of Regulation (EC) No 1107/2009 as regards uniform principles for the evaluation and authorisation of plant protection products, OJ L 378, 27.10.2009, p. No. OJ L 155, 11.6.2011 p. 127;

8.

Regulation (EU) No 547/2011 on the implementation of Regulation (EC) No 1107/2009 as regards the labelling requirements for plant protection products, OJ L 378, 27.10.2009, p. No. OJ L 155 of 11.6.2011 p. 176.

Berlakovich